Chronic Systolic Heart FailurePhase 2/3FIRSTNCT02188082
Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）
A Phase 2/3 study testing IvabRadine hemisulfate Sustained-release Tablets in people with Chronic Systolic Heart Failure, run by Jiangsu HengRui Medicine Co., Ltd. at 12 sites in China.
Trial summary
Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to severe chronic systolic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Systolic Heart Failure
- What is being tested?
- IvabRadine hemisulfate Sustained-release Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 12 sitesChina
- Study dates
- May 2014to Aug 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged from 18 to 75 years, males or females
- Willing to provide written informed consent
- NYHA Class II, III, or IV for≥4 weeks, in stable clinical condition for
- ≥4 weeks
- Optimized and unchanged chronic heart failure medications and dosages for≥4 weeks
- Sinus rhythm with resting heart rate≥70 b.p.m.
- Left-ventricular systolic dysfunction, with ejection fraction≥40% documented within previous 1 month
Who cannot join
- Unstable cardiovascular condition(for example, hospital admission for worsening heart failure)
- Recent (<2 months) myocardial infarction or recent or scheduled coronary revascularization
- Stroke or transient cerebral ischaemia within previous 4 weeks
- Severe primary valvular disease
- Scheduled surgery of valvular heart disease
- Active myocarditis
Show all 24Show fewer
- Congenital heart diseases
- peripartum cardiomyopathy
- hyperthyroid heart disease
- On list for cardiac transplantation
- Cardiac resynchronization therapy started within previous 6 months
- Pacemaker with atrial or ventricular pacing (except biventricular pacing)˃40% of the time, or with stimulation threshold at the atrial or ventricular level˃60 b.p.m.
- Permanent atrial fibrillation or flutter
- Sick sinus syndrome, sinoatrial block, second and third degree atrio-ventricular block
- History of symptomatic or sustained (≥30 s) ventricular arrhythmia unless a cardioverter/defibrillator implanted
- Cardioverter/defibrillator shock within previous 6 months
- Family history or congenital long QT syndrome or treated with selected QT-prolonging products(except amiodarone)
- Contraindication or intolerance to ivabradine or lactulose
- Severe or uncontrolled hypertension (SBP≥180 mmHg or DBP≥110 mmHg)
- known anaemia(Hb<100 g/L)
- Known moderate or severe liver disease(ALT/AST˃3ULN), known severe renal disease(Cr˃2ULN)
- Pregnant or lactating women and women planning to become pregnant
- Use of an investigational drug within 30 days of enrollment
- Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
The military general hospitla of Beijing PLA
Beijing, Beijing Municipality
Junxia Li
Junxia Li
- Not yet recruiting
the First Hospital of Jilin University
Changchun, Jilin
Yu Zhang
Yu Zhang
- Not yet recruiting
The first affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, 310003
Xiaosheng Hu
Xiaosheng Hu
- Not yet recruiting
Hangzhou First People'S Hospital
Hangzhou, Zhejiang, 310006
Yizhou Xu
Yizhou Xu
- Recruiting
The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, 310009
Jianan Wang, doctor
Jianan Wang, doctor
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Ming Zhong
Ming Zhong
- Not yet recruiting
the Second Hospital of Shandong University
Jinan, Shandong
Qinghua Lu
Qinghu Lu
- Not yet recruiting
shengjing hospital of China medical university
Shenyang, Liaoning
Shumei Ma
Shumei Ma
- Not yet recruiting
The second affiliated hospital of suzhou university
Suzhou, Jiangsu
Yang Jiao
Yang Jiao
- Not yet recruiting
The first affiliated hospital of wenzhou medical university
Wenzhou, Zhejiang, 325000
Weijian Huang
Weijian Huang
- Not yet recruiting
The second affiliated hospital of wenzhou medical university
Wenzhou, Zhejiang
Jifei Tang
Jifei Tang
- Not yet recruiting
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001
Xiang Gu
Xiang Gu
About this study
Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to severe chronic systolic heart failure.
- Conditions
- Chronic Systolic Heart Failure
- Being tested
- IvabRadine hemisulfate Sustained-release Tablets, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabRadine hemisulfate Sustained-release TabletsDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| IvabRadine hemisulfate Sustained-release Tablets | Experimental | 5-15mg qd Receives: Drug: IvabRadine hemisulfate Sustained-release Tablets |
| placebo | Placebo comparator | 5-15mg qd Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram
Measured: baseline and week 32
Secondary outcomes (6)
Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF)
Measured: baseline and week 32
incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality
Measured: baseline and week 32
change from baseline in distance of 6-minute walking test
Measured: baseline and week 32
change from baseline in heart rate
Measured: baseline and week 32
change from baseline in scores of Kansas City Cardiomyopathy Questionnaire
Measured: baseline and week 32
change from baseline in NT-proBNP
Measured: baseline and week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Systolic Heart FailureStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianan Wang, Doctor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188082
- Sponsor's protocol ID
- LSQYFBLDHF2013
- Acronym
- FIRST
- Status last verified
- May 2014
- First submitted
- 9 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ye F, Wang X, Wu S, Ma S, Zhang Y, Liu G, Liu K, Yang Z, Pang X, Xue L, Lu S, Zhong M, Li J, Yu H, Lou D, Cui D, Xie X, Wang J; FIRST Investigators. Sustained-Release Ivabradine Hemisulfate in Patients With Systolic Heart Failure. J Am Coll Cardiol. 2022 Aug 9;80(6):584-594. doi: 10.1016/j.jacc.2022.05.027.
PubMed 35926931
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）
- ClinicalTrials.gov ID
- NCT02188082
- Acronym / sponsor ID
- FIRST / LSQYFBLDHF2013
- Conditions
- Chronic Systolic Heart Failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2017 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to severe chronic systolic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IvabRadine hemisulfate Sustained-release Tablets | Experimental | Drug: IvabRadine hemisulfate Sustained-release Tablets5-15mg qd |
| placebo | Placebo comparator | Drug: placebo5-15mg qd |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged from 18 to 75 years, males or females
- Willing to provide written informed consent
- NYHA Class II, III, or IV for≥4 weeks, in stable clinical condition for
- ≥4 weeks
- Optimized and unchanged chronic heart failure medications and dosages for≥4 weeks
Key exclusion criteria (24 listed)
- Unstable cardiovascular condition(for example, hospital admission for worsening heart failure)
- Recent (<2 months) myocardial infarction or recent or scheduled coronary revascularization
- Stroke or transient cerebral ischaemia within previous 4 weeks
- Severe primary valvular disease
- Scheduled surgery of valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvabRadine hemisulfate Sustained-release Tablets | Drug | IvabRadine hemisulfate Sustained-release Tablets |
| placebo | Drug | placebo |
Primary outcome
Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram
Time frame: baseline and week 32
6 secondary outcomes
Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF)
Time frame: baseline and week 32
incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality
Time frame: baseline and week 32
change from baseline in distance of 6-minute walking test
Time frame: baseline and week 32
change from baseline in heart rate
Time frame: baseline and week 32
change from baseline in scores of Kansas City Cardiomyopathy Questionnaire
Time frame: baseline and week 32
change from baseline in NT-proBNP
Time frame: baseline and week 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- Derived from this study: PubMed 35926931Ye F, Wang X, Wu S, Ma S, Zhang Y, Liu G, Liu K, Yang Z, Pang X, Xue L, Lu S, Zhong M, Li J, Yu H, Lou D, Cui D, Xie X, Wang J; FIRST Investigators. Sustained-Release Ivabradine Hemisulfate in Patients With Systolic Heart Failure. J Am Coll Cardiol. 2022 Aug 9;80(6):584-594. doi: 10.1016/j.jacc.2022.05.027.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianan Wang, Doctor principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IvabRadine hemisulfate Sustained-release Tablets in people with Chronic Systolic Heart Failure, run by Jiangsu HengRui Medicine Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianan Wang, doctor (0571-87315001, wang_jian_an@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram (time frame: baseline and week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02188082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.